Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate: what the FDA reviewed for dog products
3 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Mometamax™ Otic Suspension (NADA/ANADA 141-177)
Mometamax™ Otic Suspension NADA 141-177, Original approval, December 05, 2000; sponsor Intervet, Inc.; species: Dogs; foi_id 687; FDA PDF
Indication
Treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.
Dose regimen
4 drops (dogs under 30 lbs) or 8 drops (dogs 30 lbs or more) from the 15g or 30g bottle; 2 or 4 drops respectively from the 215g bottle, Otic (aural), into the ear canal after cleaning and drying; eardrum must be intact, twice daily, 7 consecutive days
For dogs weighing less than 30 lbs, instill 4 drops from the 15g or 30g bottle (2 drops from the 215g bottle) of MOMETAMAX™ Otic Suspension twice daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops from the 15g or 30 g bottle (4 drops from the 215g bottle) twice daily into the ear canal. Therapy should continue for 7 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | percutaneous systemic absorption 2% in dogs (6% in rabbits) | Single topical application of radiolabelled 1 mg/g mometasone furoate ointment to intact skin of rats, rabbits and dogs, 5-7 day collection | In all three species, systemic absorption was found to be minimal and ranged from 2% in dogs to 6% in rabbits over a 5-7 day period. |
Target-animal safety
dose multiples 12.5X (0.5 g/kg), 25X (1 g/kg), 50X (2 g/kg); duration Daily topical application for six months; animals 20 male and 20 female Beagles (4/sex/group, five groups).
Animals: 20 male and 20 female Beagle dogs approximately 11 months of age at the onset of the study. Body weight ranged from 6.4 to 11.8 kg. Dogs were randomly assigned to five groups (4/sex/group).
| Finding | Quote |
|---|---|
| Muscle wasting by study end in two vehicle, three 0.5 g/kg, three 1 g/kg and four 2 g/kg dogs. | At the end of the study, two vehicle, three 0.5 g/kg, three 1 g/kg and four 2 g/kg-dosed dogs showed muscle wasting. |
| Transient erythema at the application site increasing with dose (1/8 vehicle, 1/8, 2/8, 4/8 medicated groups); papules/pustules and desquamation in medicated groups. | Transient erythema was seen in 1/8 of the vehicle, 1/8 of the 0.5 g/kg, 2/8 of the 1 g/kg and 4/8 of the 2 g/kg-dosed animals. |
| Minimal to moderate decreases in absolute lymphocyte counts in most medicated dogs. | Minimal to moderate decreases in absolute lymphocyte counts were observed for most animals in all three medicated groups. |
| Adrenal cortical atrophy (zona fasciculata) in all medicated males and four medicated females. | All males and four females (2 animals from the 1 g/kg and two from the 2 g/kg groups) had some degree of adrenal cortical atrophy with the zona fasciculata being the most affected. |
| Skin thinning at non-dosed sites indicating systemic absorption. | Skin thinning also occurred at the non-dosed areas for medicated dogs and indicated systemic absorption of the drug substance. |
| Conclusion: effects typical of corticosteroid therapy at 12.5-50X; doses far exceed the otic dose; mometasone 0.1% safe for labeled use. | Mometasone furoate ointment (0.1%) applied topically once daily to Beagle dogs for six months at approximately 12.5, 25 and 50 times the recommended label dose produced adverse effects typical of corticosteroid therapy. |
Effectiveness
Positive-controlled multicenter field study (Study V95-271, 13 investigators): Mometamax vs Otomax ointment (betamethasone valerate in place of mometasone), 4 or 8 drops per affected ear twice daily for 7 days in dogs with concurrent bacterial and Malassezia otitis externa; re-evaluation 8-10 days after treatment; non-inferiority judged by lower 90% confidence bound of the difference in percent improved of -10%.; n = 141 Mometamax and 146 Otomax (safety); 117 and 123 (effectiveness); primary endpoint: Improvement Day 0 to Day 8 in discomfort, pinna erythema, canal erythema, canal swelling, exudate (presence, quantity, type, odor) and owner/investigator final evaluation; result: Mometamax met the 'at least as good as' criterion for discomfort, pinna erythema, odor of exudate, investigator and owner evaluations (e.g. investigator excellent/good 91.5% vs 91.9%); presence, type and quantity of exudate and canal erythema did not meet the criterion and canal swelling was borderline (-10.6%), but overall Mometamax was judged at least as good as Otomax.
Number of Subjects: 141 treated with Mometamax and 146 treated with the control drug, Otomax® were evaluated for safety. Of these cases, 117 dogs treated with Mometamax and 123 dogs treated with Otomax® were included in the evaluation for effectiveness.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Any adverse reaction (all reverted to normal after treatment) | 3 dogs | 6 dogs (Otomax) | Nine dogs out of 287 cases (both Mometamax and Otomax®) exhibited adverse reactions (6 dogs treated with Otomax® and 3 dogs treated with Mometamax). |
| Bilateral hyperemia of pinna | 1 dog | Adverse reactions reported in dogs treated with Mometamax included: bilateral hyperemia of pinna (1 dog), vomition during treatment (1 dog), and diarrhea (1 dog). | |
| Vomition during treatment | 1 dog | Adverse reactions reported in dogs treated with Mometamax included: bilateral hyperemia of pinna (1 dog), vomition during treatment (1 dog), and diarrhea (1 dog). | |
| Diarrhea | 1 dog | Adverse reactions reported in dogs treated with Mometamax included: bilateral hyperemia of pinna (1 dog), vomition during treatment (1 dog), and diarrhea (1 dog). |
Extraction notes: Original NADA (2000). The General Information section has no species field; 'Dogs' is taken from the product title and indication. Target animal safety for gentamicin/clotrimazole is incorporated by reference to Otomax (NADA 140-896); the recorded study is the six-month dermal toxicity study of mometasone furoate 0.1% ointment (dose multiples stated by the summary relative to the label dose, doses 0.5, 1 and 2 g/kg applied to about 10% of body surface). The PK entry is a percutaneous absorption figure, not a plasma PK parameter. Otomax-group adverse reactions (inflammation of pinna, ear canal inflammation, diarrhea then constipation, ataxia, reluctance to accept treatment, deafness; 1 dog each) are not recorded as rows. Indication quote reproduces the extraction artefact 'pachyderm atis'. The extracted text carries a private-use character (U+F6DB, the trademark glyph) after 'Mometamax' in several sentences; quotes include it verbatim.
Mometamax™ Otic Suspension NADA 141-177, Supplemental approval, January 09, 2003; sponsor Intervet, Inc.; species: Dogs; foi_id 688; FDA PDF
Indication
Treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta hemolytic streptococci).
Dose regimen
4 drops (dogs under 30 lbs) or 8 drops (dogs 30 lbs or more) from the 15-g or 30-g bottle; 2 or 4 drops respectively from the 215-g bottle, Otic, once daily (this supplement adds the once-daily frequency), 7 days
For dogs weighing less than 30 lbs, instill 4 k. Recommended Dosage: drops from the 15-g and 30-g bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lbs or more, instill 8 drops from the 15- or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once daily for 7 days.
Effectiveness
Negatively controlled multicenter field study (Study C00-055-00, 8 investigators): Mometamax vs excipient base (mineral oil in plasticized hydrocarbon gel), 4 or 8 drops per affected ear once daily for 7 days in dogs with concurrent bacterial and Malassezia otitis externa (baseline clinical score sum ≥ 5); re-evaluation 2-7 days after treatment; primary variables analysed by exact Mantel-Haenszel stratified by site.; n = 47 Mometamax and 48 excipient (safety); 39 and 36 (effectiveness); primary endpoint: Improvement Day 0 to Day 8 in discomfort, ear canal erythema and ear canal swelling; result: Percent improved was significantly greater with Mometamax than placebo for discomfort 70.3% vs 41.7% (p=0.0326), canal erythema 74.4% vs 36.1% (p=0.0016) and canal swelling 71.4% vs 48.5% (p=0.0436); odor of exudate and investigator evaluation also significant; once-daily Mometamax concluded safe and effective.
Number of Subjects: 47 treated with Mometamax and 48 treated with excipient base (mineral oil in a plasticized hydrocarbon gel) were included for assessment of safety. Of these cases, 39 dogs treated with Mometamax and 36 treated with excipient base were included in the evaluation for effectiveness.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Any adverse reaction (pivotal once-daily field study) | none reported | none reported | There were no adverse reactions reported during the study in either of the Mo metamax or placebo control groups. |
| Ataxia, proprioceptive deficits and increased water consumption (separate field study not used for effectiveness) | less than 1% of 117 dogs | In a field study not used to support effectiveness due to problems with the study design, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 117 dogs following once-daily treatm ent with Mometamax™ Otic Suspension. |
Extraction notes: Supplemental NADA (2003) adding once-daily administration; supported by one field study. Target animal safety is incorporated by reference to the original approval (foi 687). The recommended dosage in the General Information section is interleaved with the field label 'k. Recommended Dosage:' in the extracted text and is quoted as extracted. Quotes reproduce the extraction artefacts 'Mo metamax' and 'treatm ent' and the private-use character (U+F6DB, trademark glyph) that follows 'Mometamax' in the extracted text. Result percentages come from Table 1 (flattened).
Mometamax™ Otic Suspension NADA 141-177, Supplemental approval, June 01, 2005; sponsor Intervet, Inc.; species: Dogs; foi_id 689; FDA PDF
Indication
Treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta hemolytic streptococci).
Dose regimen
4 drops (dogs under 30 lbs) or 8 drops (dogs 30 lbs or more) from the 7.5g, 15g or 30g bottle; 2 or 4 drops respectively from the 215g bottle, Topical (otic), once daily, 7 days
For dogs weighing less than 30 lbs, instill 4 drops from the 7.5g, 15g, or 30g bottle into the ear canal (2 drops from the 215g bottle) or, for dogs weighing 30 lbs or more, instill 8 drops from the 7.5g, 15g or 30g bottle into the ear canal (4 drops from the 215g bottle), once daily for 7 days.
Extraction notes: Supplemental NADA (2005) adding a 7.5 g package size (Category I change). No new effectiveness or safety data; both are incorporated by reference to the original approval (foi 687) and the 2003 once-daily supplement (foi 688). The indication quote stops at 'and bacteria' because a page header interrupts the sentence in the extracted text.
Reproduce: foi_structured_search(query="Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).